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Relapsed/Refractory Autoimmune DiseasesNCT07655453

Early Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of STR-P005

A study testing STR-P005 in people with Relapsed/Refractory Autoimmune Diseases, run by Starna Therapeutics.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This study is a single-center, single-arm, open-label, investigator-initiated early exploratory clinical trial designed to evaluate the safety and efficacy of STR-P005 in subjects with relapsed/refractory autoimmune diseases. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Relapsed/Refractory Autoimmune Diseases
What is being tested?
STR-P005
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
No sites listed yet
Study dates
1 Aug 2026to 30 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate in this study and sign the informed consent form.
  • Aged 18 to 75 years (inclusive).
  • Confirmation of positive CD19 expression on peripheral blood B cells by flow cytometry.
  • Adequate organ function:
  • Hematology: Absolute Neutrophil Count (ANC) ≥1.0×10^9^/L, Absolute Lymphocyte Count (ALC) ≥0.1×10^9^/L, Hemoglobin ≥80 g/L, Platelet count (PLT) ≥50×10^9^/L. Blood transfusion and growth factors cannot be used within 7 days prior to eligibility screening to meet these requirements.
  • Coagulation: International Normalized Ratio (INR) ≤1.5 × Upper Limit of Normal (ULN), and Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN.
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  • Liver function: Serum AST, ALT ≤3.0 × ULN, Total Bilirubin ≤1.5 × ULN (for subjects with Gilbert's syndrome, Total Bilirubin <3.0 × ULN).
  • Renal function: Serum creatinine ≤1.5 × ULN or Creatinine Clearance (CrCl) ≥60 mL/min (calculated by Cockcroft-Gault formula); if with renal involvement, CrCl ≥45 mL/min.
  • Cardiac function: New York Heart Association (NYHA) Class I or II, and Left Ventricular Ejection Fraction (LVEF) ≥50% by Echocardiography (ECHO), and no clinically significant arrhythmia, pericardial effusion, valvular disease, or Ischemic Heart Disease (IHD) within 8 weeks prior to screening.
  • Oxygen saturation: ≥92% while breathing room air at rest (by pulse oximetry); no clinically significant pleural effusion.
  • -

Who cannot join

  • Patients who have received any cell immunotherapy in the past, except where there is evidence that the engineered immune cells have disappeared and peripheral blood B cells are still present.
  • Unable to meet the following washout periods for therapeutic drugs:
  • Use of therapeutic doses of corticosteroids (Prednisone ≥20mg/day or equivalent dose of other corticosteroids) within 72 hours prior to first dose, but topical or inhaled steroids are allowed.
  • Use of mycophenolate mofetil or its derivatives, azathioprine, calcineurin inhibitors (e.g., tacrolimus, cyclosporine), mTOR inhibitors (e.g., sirolimus, everolimus), JAK inhibitors (e.g., tofacitinib, ruxolitinib, upadacitinib) within at least 2 weeks prior to screening.
  • Use of cytotoxic drugs such as cyclophosphamide, methotrexate within at least 3 weeks prior to screening.
  • Use of belimumab, B-cell targeting antibodies (e.g., anti-CD20) within at least 1 month prior to screening; anti-cytokine antibodies within at least 2 months; natalizumab, anti-CD52 mAb, anti-CD38 mAb, ATG within at least 3 months.
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  • Other monoclonal antibodies, bispecific antibodies, trispecific antibodies, antibody-drug conjugates (ADC), or any B-cell depleting drugs require a washout of 3 months or 5 half-lives (whichever is shorter) prior to screening.
  • Undergone plasmapheresis, plasma separation, hemodialysis, intravenous immunoglobulin (IVIG) within 2 weeks prior to screening.
  • History of ≥ Grade 2 bleeding within 30 days prior to screening; or requiring long-term continuous use of anticoagulants (e.g., warfarin, low molecular weight heparin, or Factor Xa inhibitors), except if INR ≤ 1.5 × ULN.
  • Severe renal disease: Severe lupus nephritis within 8 weeks prior to screening [defined as urine protein > 6g/24 hours or serum creatinine > 2.5 mg/dL or 221 μmol/L or creatinine clearance (Cockcroft-Gault formula) < 30 mL/min], or active nephritis requiring treatment with prohibited medications, or requiring prednisone >100mg/day or equivalent corticosteroid for ≥14 days.
  • Severe pulmonary disease within 3 months prior to screening, such as moderate-to-severe pulmonary hypertension (mean pulmonary artery pressure > 60 mmHg by echocardiography), requiring oxygen therapy via reservoir mask or non-invasive/invasive mechanical ventilation at screening.
  • Occurrence of lupus crisis within 3 months prior to screening, such as active central nervous system lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe granulocytopenia, severe myocardial injury, severe lupus pneumonitis or pulmonary hemorrhage, severe lupus hepatitis, severe vasculitis, etc.
  • History or related symptoms of active non-lupus-induced central nervous system disease (excluding isolated trigeminal nerve disease) within 6 months prior to screening, including but not limited to: cerebrovascular disease, encephalitis, brain injury, aneurysm, cerebellar disease, organic brain syndrome, Parkinson's disease, and symptoms such as epilepsy, convulsions, aphasia, dementia, etc.
  • Occurrence of any of the following cardiovascular diseases within 6 months prior to screening (including but not limited to):
  • Congestive heart failure, myocardial infarction, unstable angina pectoris, coronary angioplasty, stent implantation, coronary/peripheral artery bypass surgery.
  • Severe arrhythmias requiring treatment (e.g., sustained ventricular tachycardia, ventricular fibrillation, Torsade de Pointes); congenital long QT syndrome, left anterior hemiblock (bifascicular block), complete left bundle branch block or high-grade AV block; history of severe non-ischemic cardiomyopathy; asymptomatic right bundle branch block is allowed for study entry.
  • Uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >100 mmHg), history of hypertensive crisis or hypertensive encephalopathy.
  • Current active cardiac involvement, such as pericarditis, pericardial effusion, and myocarditis.
  • Active tuberculosis or latent tuberculosis at screening (defined as positive tuberculin skin test or interferon-gamma release assay without clinical symptoms or radiographic evidence).
  • Screening results showing HBV-DNA, HCV-RNA, CMV-DNA above the laboratory's detection limit, or HIV antibody positive.
  • Presence of uncontrolled fungal, bacterial, viral or other infections deemed unsuitable for study participation by the investigator.
  • Presence of uncontrolled diabetes mellitus (HbA1c ≥ 7.0%); and uncontrolled thyroid disease (TSH > 10 mIU/L or < 0.1 mIU/L, and FT4 outside normal range).
  • History of major organ transplant (e.g., heart, lung, kidney, liver) or history of allogeneic hematopoietic stem cell transplant within 12 weeks or autologous hematopoietic stem cell transplant within 6 weeks prior to screening.
  • Congenital immunoglobulin deficiency.
  • Thrombotic Thrombocytopenic Purpura (TTP)/Thrombotic Microangiopathy (TMA).
  • Concomitant history of other autoimmune diseases (including but not limited to eosinophilic granulomatosis with polyangiitis, cryoglobulinemic vasculitis, inclusion body myositis, anti-glomerular basement membrane disease, Behçet's disease, or Takayasu's arteritis) requiring systemic treatment, besides the target indications.
  • Family history of non-IIM conditions such as drug-induced myopathy, HIV-associated myopathy.
  • History or concurrent presence of other active malignancies, including patients with malignancy-associated polymyositis/dermatomyositis. Exceptions: carcinoma in situ of the cervix, non-invasive basal cell or squamous cell skin cancer, locally treated prostate cancer, ductal carcinoma in situ of the breast post-resection, and papillary thyroid cancer that have been cured and without recurrence for at least 2 years.
  • History of hypersensitivity or life-threatening reaction to the study drug or any of its components or formulation ingredients.
  • Pregnant or breastfeeding women.
  • Received any live attenuated vaccine within 6 weeks prior to first dose, or planned to receive one within 3 months after treatment.
  • Participation in another interventional clinical study and received an active investigational drug within 3 months prior to signing ICF, or intention to participate in another clinical trial or receive treatment for autoimmune diseases outside the protocol during the entire study period.
  • Patients with mental illness such as depression or suicidal tendencies.
  • Other factors considered by the investigator to make the subject unsuitable for enrollment or affect the subject's participation or completion of the study.
  • -

About this study

Official title: Early Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of STR-P005 in the Treatment of Relapsed/Refractory Autoimmune Diseases

This study is a single-center, single-arm, open-label, investigator-initiated early exploratory clinical trial designed to evaluate the safety and efficacy of STR-P005 in subjects with relapsed/refractory autoimmune diseases.

The study will employ the traditional "3+3" dose escalation model, setting up 3 dose groups: Amg/kg, Bmg/kg, C mg/kg. Dose Group 1 will serve as the starting dose, with two cohorts A and B within this group aimed at optimizing the dosing frequency of STR-P005. Cohort A will receive dosing every 3 days (Q3D), on D1, D4, D7 (3 doses) constituting one cycle, which can be repeated for 2 cycles. Cohort B will receive dosing every 4 days (Q4D), on D1, D4 (2 doses) constituting one cycle, which can be repeated for 2 cycles. Based on the preliminary safety data, efficacy information, and PK/PD parameters obtained from Cohorts 1A and 1B, the investigators will select the superior regimen and escalate sequentially to Dose Groups 2 and 3. If no MTD is found after dose escalation through the 3 groups, based on all available preliminary safety data, efficacy information, and PK/PD parameters, higher doses may be added for further exploration of safety and efficacy after discussion by the SRC.

Being tested
STR-P005
Medical subject headings
Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STR-P005Drug

    Dose escalation follows the traditional "3+3" design, with multiple, multi-cycle intravenous infusions

Study groups in NCT07655453
Study groupRoleWhat they receive
STR-P005 Dose groupExperimentalNot described
Receives: Drug: STR-P005

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Grade and frequency of Adverse Events (AEs), Serious Adverse Events (SAEs), laboratory abnormalities, and Adverse Events of Special Interest by CTCAE v6.0

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion30 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07655453
Sponsor's protocol ID
STR-P005-004
Status last verified
Jun 2026
First submitted
10 Jun 2026
Last updated
17 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing STR-P005 in people with Relapsed/Refractory Autoimmune Diseases, run by Starna Therapeutics.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Grade and frequency of Adverse Events (AEs), Serious Adverse Events (SAEs), laboratory abnormalities, and Adverse Events of Special Interest by CTCAE v6.0 (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07655453.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.

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